FDA.reportPublic FDA data

Aspirin 81 MG

Product NDC
41250-780
11-digit product format
412500780
Labeler code
41250
Product ID
41250-780_243455d6-158d-31fa-e063-6294a90ad35d
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Meijer
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-01
Marketing end
2026-12-31
Substance
ASPIRIN
Active strength
81 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-78041250-780-01DDiscontinued by firm2026-10-05
excluded packagepackage41250-78041250-780-14DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin 81 MG

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3e5711c-9529-4eec-871d-de8efa858b86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-780-01Aspirin 81 MG1 in 1 PACKAGETABLET, DELAYED RELEASE15
41250-780-01Aspirin 81 MG120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1205
41250-780-06Aspirin 81 MG200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE2005
41250-780-06Aspirin 81 MG1 in 1 PACKAGETABLET, DELAYED RELEASE15
41250-780-12Aspirin 81 MG300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3005
41250-780-14Aspirin 81 MG32 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE325
41250-780-14Aspirin 81 MG1 in 1 PACKAGETABLET, DELAYED RELEASE15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-780ASPIRIN 81 MG (ASPIRIN) TABLET, DELAYED RELEASE [MEIJER]5Current NDC, Legacy NDC, 7 package rows20241013_b3e5711c-9529-4eec-871d-de8efa858b86.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNb3e5711c-9529-4eec-871d-de8efa858b865
308416aspirin 81 MG Delayed Release Oral TabletSCDb3e5711c-9529-4eec-871d-de8efa858b865
308416ASA 81 MG Delayed Release Oral TabletSYb3e5711c-9529-4eec-871d-de8efa858b865
308416aspirin 81 MG Enteric Coated Oral TabletSYb3e5711c-9529-4eec-871d-de8efa858b865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-780-01412500780011 BOTTLE, PLASTIC in 1 PACKAGE (41250-780-01) > 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-03-010000-00-00NoNoCurrent
41250-780-06412500780061 BOTTLE, PLASTIC in 1 PACKAGE (41250-780-06) / 200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2017-12-012026-12-31NoNoCurrent
41250-780-1241250078012300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (41250-780-12) 2014-12-012026-12-31NoNoCurrent
41250-780-14412500780141 BOTTLE, PLASTIC in 1 PACKAGE (41250-780-14) > 32 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2018-07-010000-00-00NoNoCurrent